Status:
TERMINATED
Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM
Eligibility Criteria
Inclusion
- Parts A and Part B of the study (maximum age 45 years):
- Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study.
- Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
Exclusion
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Part C of the study (maximum age 65 years):
- Inclusion criteria:
- Drug naive patients with T2DM or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (HbA1c \>7 %and \<10 %) Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)
- Exclusion criteria:
- Poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms
- Any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, Cushing's syndrome, Addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., HIV/AIDS or organ-transplant), or history of myocardial infarction, congestive heart failure defined as New York Heart Association (NYHA) stage II and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of Long QT Syndrome
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00707590
Start Date
August 1 2008
End Date
November 1 2008
Last Update
February 10 2009
Active Locations (1)
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1
Local Institution
Québec, Quebec, Canada, G1P 0A2